Duns Number:080354039
Device Description: Laser Safety Sport Goggle, OD 5+ @ 800nm-820nm EN207: 800-820 DIR LB5 PF w/ Box and Lanyar Laser Safety Sport Goggle, OD 5+ @ 800nm-820nm EN207: 800-820 DIR LB5 PF w/ Box and Lanyard
Catalog Number
EYE
Brand Name
Laser Safety Goggles (Sport Frame)
Version/Model Number
EYE
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 31, 2020
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
00c80030-b120-4905-b53e-8cb8f589604d
Public Version Date
November 03, 2020
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |